Locations

Population of South Eastern Europe Countries

The total population of the countries in which Rotrial Contract Research can conduct clinical trials is 27.5 million people, the largest country being Romania (20 million) followed by Bulgaria (7.5 million).

Regulatory Environment

Both Romania and Bulgaria have adopted the EU Clinical Trials Directives.

Usually it takes between 2 and 3 months to obtain regulatory and EC approval in those 2 countries.

Why should you conduct studies in our region?

Quality:

There is an abundance of high quality investigational sites in South East Europe because the number of teaching hospitals, university clinics and postgraduate medical schools is high. More practitioners are employed by teaching hospitals and university clinics compared to Western Europe standards. GCP guidelines are fully implemented, and GCP training of the investigators is compulsory required by the regulatory authorities. The overall quality of work delivered by investigational sites is high, comparable to Western Europe and the US.

High recruitment rate:

Consistently there is high recruitment performance throughout the region and this is maintained by many factors:

  • A large heterogeneous patient population,
  • A wide availability of naive patients,
  • Shortage of available therapy,
  • The insufficient availability (sometimes total lack) of preventive medicine,
  • Patient willingness to participate in clinical trials sponsored by Western companies,
  • Availability of multi-specialty medical institutions with highly educated medical personnel. Investigators are motivated to take part in clinical trials and perform well, as they largely acknowledge that co-operating with Western pharmaceutical companies in scientific research is a sign of academic distinction, merit, and prestige,
  • Salaries in the healthcare sector in all countries of our operations are incredibly low in comparison with the Western correspondents. Therefore the investigator fee represents an important motivation factor for Southeastern Europe physicians.

    • Logistics and communication:

    Our synergic operations in Romania and Bulgaria facilitates your access to highly specialised & fully trained ICH-GCP investigators that have a vast experience in running clinical trials .The site staff (English-speaking investigators in a dense network of healthcare facilities) makes a great deal of efforts to ensure the studies are run according to the protocol and in line with local and international regulations. The guidance provided by CRO's and sponsors is largely accepted and there is a refreshing willingness to learn and improve practice.

    Cost-effectiveness:

    Both the monitoring and investigator fees of a clinical trial in Romania and Bulgaria are significantly lower than those in the Western Europe. The monitoring costs rise probably to 50 - 70 % of the corresponding Western Europe demands while the investigator & hospital fees levels always stay meaningful lover compared to same Western European standards. Even other additional accountable costs, such as travel, accommodation and postage are also considerably lower.